HIV InfectionsNCT05043129
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
An observational study of HIV Infections and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Covid19
- What is being tested?
- Biological/Vaccine: SARS-COV-2 VACCINE
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2021to 4 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV infected persons vaccinated with COVID-19 vaccine
Who may be able to join
- HIV infection group: a. The HIV positive diagnosis is clear; b. 18-80 years old; c. Has been vaccinated against the COVID-19 ; d. Volunteer to participate in the project;
- Healthy control group: a. HIV negative; b. Age 18-80 years old; c. The COVID-19 vaccination has been completed; d. Volunteer to participate in the project
Who cannot join
- Previous confirmed case of COVID-19
- confirmed contact history of COVID-19
- vaccination contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China
Chongqing
DACHUAN CAI, PHD, 18323409779, 597521685@qq.com
DAZHI ZHANG, PHD, 13452382818, dzhzhang@yahoo.com
About this study
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). People infected with human immunodeficiency virus (HIV) are affected by their underlying diseases and are listed by the World Health Organization (WHO) as a high-risk population of SARS-CoV-2 infection.To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with human immunodeficiency virus infection , and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Read the detailed description
People infected with human immunodeficiency virus (HIV), affected by their underlying diseases, are listed by the World Health Organization (WHO) as a high-risk population for SARS-CoV-2 infection.. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, CD4, HIV virus load, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and HIV infenction people after vaccination ( 1, 3, 6 months after vaccination). The adverse reactions related to the vaccine were recorded.
- Conditions
- HIV Infections, Covid19
- Being tested
- Biological/Vaccine: SARS-COV-2 VACCINE
- Medical subject headings
- HIV Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: SARS-COV-2 VACCINEBiological
The antibody titer and adverse reactions were observed.
| Study group | Role | What they receive |
|---|---|---|
| HIV infenction/AIDS | experimental group Receives: Biological: Biological/Vaccine: SARS-COV-2 VACCINE | |
| Healthy population | Control group Receives: Biological: Biological/Vaccine: SARS-COV-2 VACCINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events after injection
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 1 month after vaccination
Number of participants with adverse events after injection
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 3 months after vaccination
Number of participants with adverse events after injection
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 6 months after vaccination
Secondary outcomes (3)
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 1 month
Measured: 1 month after vaccination
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 3 months
Measured: 3 months after vaccination
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 6 months
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start4 Sep 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion4 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Hong Ren, PHD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043129
- Sponsor's protocol ID
- 2021-43
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.
PubMed 32702299Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, Briner C, Kwatra G, Ahmed K, Aley P, Bhikha S, Bhiman JN, Bhorat AE, du Plessis J, Esmail A, Groenewald M, Horne E, Hwa SH, Jose A, Lambe T, Laubscher M, Malahleha M, Masenya M, Masilela M, McKenzie S, Molapo K, Moultrie A, Oelofse S, Patel F, Pillay S, Rhead S, Rodel H, Rossouw L, Taoushanis C, Tegally H, Thombrayil A, van Eck S, Wibmer CK, Durham NM, Kelly EJ, Villafana TL, Gilbert S, Pollard AJ, de Oliveira T, Moore PL, Sigal A, Izu A; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1885-1898. doi: 10.1056/NEJMoa2102214. Epub 2021 Mar 16.
PubMed 33725432Haynes BF. SARS-CoV-2 and HIV-1 - a tale of two vaccines. Nat Rev Immunol. 2021 Sep;21(9):543-544. doi: 10.1038/s41577-021-00589-w. Epub 2021 Jul 16.
PubMed 34272508Treskova-Schwarzbach M, Haas L, Reda S, Pilic A, Borodova A, Karimi K, Koch J, Nygren T, Scholz S, Schonfeld V, Vygen-Bonnet S, Wichmann O, Harder T. Pre-existing health conditions and severe COVID-19 outcomes: an umbrella review approach and meta-analysis of global evidence. BMC Med. 2021 Aug 27;19(1):212. doi: 10.1186/s12916-021-02058-6.
PubMed 34446016Ao L, Lu T, Cao Y, Chen Z, Wang Y, Li Z, Ren X, Xu P, Peng M, Chen M, Zhang G, Xiang D, Cai D, Hu P, Shi X, Zhang D, Ren H. Safety and immunogenicity of inactivated SARS-CoV-2 vaccines in people living with HIV. Emerg Microbes Infect. 2022 Dec;11(1):1126-1134. doi: 10.1080/22221751.2022.2059401.
PubMed 35369854
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT05043129
- Acronym / sponsor ID
- 2021-43
- Conditions
- HIV Infections, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 4 Sep 2022 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). People infected with human immunodeficiency virus (HIV) are affected by their underlying diseases and are listed by the World Health Organization (WHO) as a high-risk population of SARS-CoV-2 infection.To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with human immunodeficiency virus infection , and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Detailed description
People infected with human immunodeficiency virus (HIV), affected by their underlying diseases, are listed by the World Health Organization (WHO) as a high-risk population for SARS-CoV-2 infection.. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, CD4, HIV virus load, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and HIV infenction people after vaccination ( 1, 3, 6 months after vaccination). The adverse reactions related to the vaccine were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infenction/AIDS | – | Biological: Biological/Vaccine: SARS-COV-2 VACCINEexperimental group |
| Healthy population | – | Biological: Biological/Vaccine: SARS-COV-2 VACCINEControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected persons vaccinated with COVID-19 vaccine
Key inclusion criteria (2 listed)
- HIV infection group: a. The HIV positive diagnosis is clear; b. 18-80 years old; c. Has been vaccinated against the COVID-19 ; d. Volunteer to participate in the project;
- Healthy control group: a. HIV negative; b. Age 18-80 years old; c. The COVID-19 vaccination has been completed; d. Volunteer to participate in the project
Key exclusion criteria (3 listed)
- Previous confirmed case of COVID-19
- confirmed contact history of COVID-19
- vaccination contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological/Vaccine: SARS-COV-2 VACCINEThe antibody titer and adverse reactions were observed. | Biological | HIV infenction/AIDS, Healthy population |
Primary outcome
Number of participants with adverse events after injection
Time frame: 1 month after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Number of participants with adverse events after injection
Time frame: 3 months after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Number of participants with adverse events after injection
Time frame: 6 months after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
3 secondary outcomes
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 1 month after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 3 months after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 6 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Background: PubMed 32702299Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.
- Background: PubMed 33725432Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, Briner C, Kwatra G, Ahmed K, Aley P, Bhikha S, Bhiman JN, Bhorat AE, du Plessis J, Esmail A, Groenewald M, Horne E, Hwa SH, Jose A, Lambe T, Laubscher M, Malahleha M, Masenya M, Masilela M, McKenzie S, Molapo K, Moultrie A, Oelofse S, Patel F, Pillay S, Rhead S, Rodel H, Rossouw L, Taoushanis C, Tegally H, Thombrayil A, van Eck S, Wibmer CK, Durham NM, Kelly EJ, Villafana TL, Gilbert S, Pollard AJ, de Oliveira T, Moore PL, Sigal A, Izu A; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1885-1898. doi: 10.1056/NEJMoa2102214. Epub 2021 Mar 16.
- Background: PubMed 34272508Haynes BF. SARS-CoV-2 and HIV-1 - a tale of two vaccines. Nat Rev Immunol. 2021 Sep;21(9):543-544. doi: 10.1038/s41577-021-00589-w. Epub 2021 Jul 16.
- Background: PubMed 34446016Treskova-Schwarzbach M, Haas L, Reda S, Pilic A, Borodova A, Karimi K, Koch J, Nygren T, Scholz S, Schonfeld V, Vygen-Bonnet S, Wichmann O, Harder T. Pre-existing health conditions and severe COVID-19 outcomes: an umbrella review approach and meta-analysis of global evidence. BMC Med. 2021 Aug 27;19(1):212. doi: 10.1186/s12916-021-02058-6.
- Derived from this study: PubMed 35369854Ao L, Lu T, Cao Y, Chen Z, Wang Y, Li Z, Ren X, Xu P, Peng M, Chen M, Zhang G, Xiang D, Cai D, Hu P, Shi X, Zhang D, Ren H. Safety and immunogenicity of inactivated SARS-CoV-2 vaccines in people living with HIV. Emerg Microbes Infect. 2022 Dec;11(1):1126-1134. doi: 10.1080/22221751.2022.2059401.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ren, PHD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHUAN DA CAI, PHD (18323409779, 597521685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events after injection (time frame: 1 month after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043129, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.